Using CBT to Probe Psychobiobehavioral Resilience to Post-trauma Psychopathology

NCT02279290 | Completed

• 1 other identifier: K23MH103394
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized controlled trial uses a modularized cognitive behavioral resilience training (MCBRT) intervention to probe risk and resilience mechanisms linked to post-trauma psychopathology. Ninety participants with a history of interpersonal trauma during childhood or adolescence and mild to moderate distress will be randomized to MCBRT or a health education control condition. The primary aims of this proposal are to examine whether individuals who receive MCBRT demonstrate increases in psychological resilience, biological resilience, and extinction learning compared to those in the control group. This study will also explore associations between these psychobiobehavioral risk and resilience factors.

Conditions

Anxiety; Depression

Keywords

Childhood trauma

Outcome Measures

Primary Outcomes (3)

• Psychological resilience outcomes include emotion regulation (DERS), hardiness (CD-RISC), optimism (LOT-R), perceived control (SMS), social support (MSPSS), and task-oriented coping (CISS-SFT).

  Difference between the interventions in the change of psychological resilience from pre to post intervention.

  0 - 9 weeks

• Biological resilience outcomes include neuropeptide Y [NPY], dehydroepiandrosterone [DHEA], allopregnanolone [ALLO] taken from a blood draw.

  Difference between the interventions in the change of biological resilience from pre to post intervention.

  0-9 weeks

• Extinction learning will be analyzed using the fear potentiated startle data from a fear conditioning paradigm.

  Difference between the interventions in the change of extinction learning from pre to post intervention.

  0-9 weeks

Study Arms (2)

Healthy Mind Intervention (HMI)

EXPERIMENTAL

This intervention will focus on teaching individuals a way to manage acute and chronic stressors more effectively.

Behavioral: Healthy Mind Intervention (HMI)

Healthy Body Intervention (HBI)

ACTIVE COMPARATOR

This intervention will focus on important health-related topics.

Behavioral: Healthy Body Intervention (HBI)

Interventions

Healthy Mind Intervention (HMI) BEHAVIORAL

Healthy Mind Intervention (HMI) is a flexible cognitive-behavioral resilience building program. Participants will receive 8 weekly, 60-minute individual sessions of HMI. In HMI, participants will be able to select 3 areas of resilience that they want to work on.

Healthy Mind Intervention (HMI)

Healthy Body Intervention (HBI) BEHAVIORAL

The 8 weekly, 60-minute individual sessions will include the following topics: the mind-body connection, nutrition, exercise, unhealthy substances, sleep, preventing illness, and preventive care. Each session is spent providing didactic information on these topics and strategies for how to engage in behavior change in these areas.

Healthy Body Intervention (HBI)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older
• fluent in English
• history of childhood interpersonal trauma (e.g., sexual assault, physical assault, witnessing assault before age 18)
• mild to moderate distress indicated by a score of 10-20 on the depression scale, 8-14 on the anxiety scale, or 15-25 on the stress scale of the DASS-21.

You may not qualify if:

• severe distress indicated by a score \>20 on the depression scale, \>14 on the anxiety scale, or \>25 on the stress scale of the DASS-21
• DSM-5 criterion A trauma in the past month
• color blindness based on self-report (because of inability to complete the fear conditioning task)
• auditory impairment based on audiometer screening (because of inability to complete the fear conditioning task)
• lifetime psychotic or bipolar disorder
• substance abuse or dependence within past 6 months
• concurrent psychotherapy initiated within 3 months of randomization
• ongoing psychotherapy of any duration directed toward treatment of trauma-related psychopathology (e.g., CBT)
• must be on a stable dose of psychotropic or adrenergically-active medications (e.g., beta blockers) for at least 6 weeks prior to eligibility screening
• mental retardation or significant cognitive impairment
• serious medical illness or instability for which hospitalization may be likely within the next year
• significant suicidal ideation indicated by "yes" on Columbia Suicide Severity Rating Scale item 4 (active suicidal ideation with some intent to act) or enacted suicidal behaviors within 6 months prior to eligibility
• current legal actions related to trauma.

Sponsors & Collaborators

• Rush University Medical Center: lead

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Conditions

Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Alyson K Zalta, PhD

  Rush University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 22, 2014
• First Posted: October 31, 2014
• Study Start: July 13, 2015
• Primary Completion: November 14, 2018
• Study Completion: April 26, 2019
• Last Updated: June 11, 2021

Record last verified: 2021-06

Locations

US (1)